Website The Biovac Institute
The Biovac Institute requires a QA Co Ordinator to contribute to its mission of establishing and maintaining effective value creation for its biological and vaccine partners and stakeholders within its current and future commercial footprint.
Being the only one of its kind in South Africa, Biovac strives to respond to the sterile injectable needs, particularly related to vaccines and other biologicals, South Africa, Sub Saharan Africa and other developing countries.
This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to the Snr QA Officer – Vendor Management
Summary of role
Responsible for all QA Coordinated related activities including but not limited to:
- Vendor File Management
- Administrative support
- Continually strive to deliver solutions through team work that ensures continuous improvement through innovative solutions.
- Maintaining of the QA admin documentation and processes in full compliance with the current regulations and guidelines – both local and international
- Participating in project teams and supporting other relevant organizational departments and/or teams.
- Ensuring compliance in accordance with (Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974) and the organizations policies, procedures and other applicable laws.
- Participation in quality audits and support to QA team.
- Effective implementation / maintenance of quality systems & safety systems
- Continuously support and prescribe to cGMP within Biovac.
- Keep vendor certification tracker up to date
- Follow up with departments on vendor certification approval
- Coordinate and facilitate the vendor certification documentation for approval
- Issue vendor certificates
- Update and maintain Approved vendor list
Vendor file management
- Keep database of vendors and hardcopy files of vendors up to date
- Ensure all certificates in file are current and request new one’s from vendors when expired
- Send postal audits out to vendors and follow up on outstanding postal audits
- Follow up on outstanding site audit reports and observations close out
- Assist in setting up audit dates with departments
- Follow up with departments on outstanding audit reports
- Administration of all audit documentation and tracking
- Assist in the coordination and logistics of 3rd party and regulatory audits
- Assist with departmental documentation preparation for 3rd party and regulatory audits
- Assist with company response documentation preparation for 3rd party and regulatory authorities
- Ensure all documentation is filed and up-to-date
General QA administrative Support
- Issuing of Deviation, CAPA, Change control and document change control numbers and ensuring that the applicable registers are updated accordingly.
- Compiling monthly Quality Council slides for QA and assist with Quality Council preparations
- Organizing and Scheduling all ad-hoc/ recurring QA related meetings/workshops/teleconferences
- Photocopying and scanning of documentation
- Handling all general QA department queries
- Assist Release Pharmacist, Section Heads and QA Manager with gathering of information for communication purposes
- Save important correspondences such as pertinent emails, presentations, contracts, quotations, invoices to relevant folders
- Maintain project contact list and set up outlook group contact lists
- Assist in additional functions as per Business requirements requested through Release Pharmacist/ HOD
- Grade 12 / Matric/ Equivalent
- Recognition is given to Prior Learning and practical experience
Knowledge & Experience Required
- At least 2-3 years in a similar environment
- Pharma/ Biotechnology/ FMCG industry experience is highly advantageous
- Good, solid proven working experience in Microsoft office suite including Word, Power point, Excel is required.
- Microsoft Access experience will be highly advantageous.
- Office and administration work experience required
- Knowledge of supplier/vendor auditing advantageous.
- Experience in database maintenance
- Experience in having faced successfully local and/ or international quality audits.
- Experience in aseptic (sterile) manufacturing.
- May require some occasional overtime, shift and/or weekend coverage to accommodate schedules and/or project timelines
- Good understanding and experience in Excel and Access programs (Microsoft office)
- Excellent understanding and working knowledge of Vendor system
- Knowledge of internal audit process
- Aware of external pharmaceutical requirements for audits
- Good understanding and working knowledge of Quality Operations and systems.
- Knowledge of pharmaceutical industry standards and guidelines in GMP and Quality
- Documentation Management
- Environmental, Health & Safety
- Technical Report Writing
- Standard Operating Procedures
- cGMP knowledge
- Total Quality Management & Quality Management Systems
- Data development, trending & reporting
- Attention to detail
- Good Communicator
- Documentation management
- Relationship Building
- Good Written and verbal communication
- Record / documentation management
- Planning, Organising, Execution
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
If you are interested in applying for this opportunity then forward your application to email@example.com by close of business on the 30 June 2018.
Disclaimer: Biovac supports employment equity principles and for this reason, all vacancies are filled in accordance with our diversity management strategy and equity plans. Furthermore, by submitting your application you agree that Biovac may use your information and share relevant information with our recruitment and selection stakeholders involved in this process.